Systems and Methods for Positioning of Needles and Other Devices Within Body Tissue

Abstract

Systems and methods for delivering a substance (e.g., a therapeutic or diagnostic substance, drug, biologic, cells, etc.) or device (e.g., implantable device, sensor, electrode, etc.) to a specific location within a tissue mass (e.g., an organ, tumor, other mass of body tissue, etc.) that is located a spaced distance from an open or fluid-filled space, body cavity or body lumen.

1 . A system for positioning a treatment delivering location of a treatment device at a desired location within a tissue mass located near an open or fluid-filled space, body cavity or body lumen, said system comprising:
 a treatment device having a treatment delivery location that is advanceable into the tissue mass;   an anchoring member comprising a shaft and an anchor, the anchor having a radially collapsed configuration and a radially expanded configuration, the shaft being advanceable into the space, body cavity or body lumen while the anchor is in its collapsed configuration, the anchor being thereafter transitionable to an expanded configuration and the shaft being thereafter retractable to pull the anchor into abutment with a wall of the space, body cavity or body lumen; and   measuring apparatus useable to determine the distance between the location at which the anchor abuts against the wall of the space, body cavity or body lumen and a treatment-delivering location on the elongate treatment device.   
   
   
       2 . A system according to  claim 1  wherein the treatment device comprises an elongate member having a lumen through which the shaft of the anchoring member advances and retracts. 
   
   
       3 . A system according to  claim 2  wherein the treatment delivery location comprises port for infusing a substance through the same lumen through which the shaft of the anchoring member advances and retracts. 
   
   
       4 . A system according to  claim 3  wherein the treatment device has an elongate shaft and a proximal hub that includes an anchoring member port through which the anchoring member shaft extends into the lumen and an infusion port through which a substance may be infused through the lumen. 
   
   
       5 . A system according to  claim 4  wherein the treatment device further comprises an apparatus which forms a substantially fluid tight seal about the shaft of the anchoring member to deter a substance from backflowing out of the anchoring member port when said substance is being infused through the lumen. 
   
   
       6 . A system according to  claim 2  wherein the treatment device further comprises a at least one delivery lumen that is separate from the lumen through which the shaft of the anchoring member advances. 
   
   
       7 . A system according to  claim 6  wherein the treatment device has a proximal hub that includes an anchoring member port through which the anchoring member shaft extends into the through which the shaft of the anchoring member advances and retracts and a treatment delivery port through which a substance or device may be delivered through the delivery lumen. 
   
   
       8 . A system according to  claim 1  wherein the anchor comprises a balloon. 
   
   
       9 . A system according to  claim 1  wherein the anchor comprises a coiling member. 
   
   
       10 . A system according to  claim 1  wherein the measuring apparatus comprises graduated distance markings on the shaft of the anchoring member. 
   
   
       11 . A method for positioning a treatment delivery location of a treatment device within a tissue mass at a desired distance from an open or fluid-filled space, body cavity or body lumen, said method comprising the steps of:
 (A) advancing an anchoring member from the treatment device and into the space, body cavity or body lumen;   (B) causing an expandable anchor on the anchoring member to expand;   (C) retracting the anchoring member to cause the expanded anchor to abut against a wall of the space, body cavity or body lumen;   (D) measuring the distance between the treatment delivery location on the elongate treatment device and the location at which the anchor abuts against the wall of the space, body cavity or body lumen; and   (E) maneuvering the elongate treatment device as needed until the measured distance indicates that the treatment delivery location of the elongate treatment device is positioned at the desired distance from the space, body cavity or body lumen.   
   
   
       12 . A method according to  claim 11  further comprising the step of:
 delivering a treatment from the treatment delivery location into the tissue mass.   
   
   
       13 . A method according to  claim 12  wherein the treatment delivery location comprises and outlet opening and wherein the step of delivering a treatment from the treatment delivery location into the tissue mass comprises delivering a substance or implantable device out of the outlet opening and into the tissue mass. 
   
   
       14 . A method according to  claim 11  wherein the tissue mass comprises the myocardium of a subject's heart and the space, body cavity or body lumen comprises a chamber of the heart. 
   
   
       15 . A method according to  claim 11  wherein the tissue mass comprises brain tissue and the space, body cavity or body lumen comprises a ventricle of the brain. 
   
   
       16 . A method according to  claim 11  wherein the tissue mass comprises a urinary bladder tumor or mass and the space, body cavity or body lumen comprises the urinary bladder. 
   
   
       17 . A method according to  claim 11  wherein the expandable anchor comprises a balloon and wherein Step B comprises inflating the balloon. 
   
   
       18 . A method according to  claim 11  wherein the expandable anchor comprises a coiling member and wherein Step B comprises causing the coiling member to become coiled. 
   
   
       19 . A method according to  claim 11  wherein the anchoring member comprises an elongate anchoring member shaft with said anchor formed or attached thereto with graduated distance markings on the anchoring member shaft, said graduated distance markings being used in Step D to measure the distance between the treatment delivery location on the elongate treatment device and the location at which the anchor abuts against the wall of the space, body cavity or body lumen. 
   
   
       20 . A method according to  claim 12  wherein the treatment delivery location comprises at least one outlet opening through which at least one substance or device is expelled out of the elongate treatment device and wherein the step of delivering a treatment from the treatment delivery location into the tissue mass comprises expelling a substance or device out of said opening. 
   
   
       22 . A method according to  claim 20  wherein i) the tissue mass comprises an ischemic or infracted area of the myocardium of a subject's heart, ii) the space, body cavity or body lumen comprises a chamber of the heart and iii) the step of delivering a treatment from the treatment delivery location into the tissue mass comprises expelling a therapeutic substance into the ischemic or infracted area of the myocardium. 
   
   
       23 . A method according to  claim 22  wherein the therapeutic substance comprises an angiogenic agent. 
   
   
       24 . A method according to  claim 23  wherein the angiogenic agent comprises at least one substance selected from the group consisting of: peptide growth factors, small molecule drugs and other active compounds, biologically active carbohydrates, recombinant biopharmaceuticals, agents that are active in the regulation of vascular physiology, cellular and gene therapy agents, nitric oxide, agents that affect transcription or turnover of cellular mRNA or the efficiency with which specific mRNA translates into its protein product, antisense agents, hormones, soluble receptors, receptor ligands, synthetic and naturally occurring peptides, peptidomimetic compounds, specific and non-specific protease inhibitors, postaglandins, inhibitors of prostaglandin synthase and/or other enzymes involved in the regulation of prostaglandin synthesis, fibroblast growth factors (FGF's), acidic fibroblast growth factors (aFGF, FGF-II), basic fibroblast growth factors (bFGF, FGF-I), vascular endothelial growth factors (VEGF), agents that stimulate endogenous production of VEGF, platelet-derived growth factor (PDGF), purified monocyte-derived angiogenic substance (angiotropin), angiogenin, transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β) and angiogenic cell precursors. 
   
   
       25 . A method according to  claim 22  wherein the therapeutic substance comprises a cell preparation or substance that establishes new heart muscle. 
   
   
       26 . A method according to  claim 25  wherein the cell preparation or substance that establishes new heart muscle comprises at least one substance selected from the group consisting of: myocytes, pluripotent cells; embryonic stem cells, adult stem cells, mesenchymal stem cells, myoblasts, skeletal myoblasts and bone marrow mononuclear cells. 
   
   
       27 . A method according to  claim 22  wherein the therapeutic substance comprises a substance that deters ventricular remodeling or improves myocardial function. 
   
   
       28 . A method according to  claim 27  wherein the substance comprises platelet gel. 
   
   
       29 . A method according to  claim 28  wherein the platelet gel is injected through a lumen of the treatment device. 
   
   
       30 . A method according to  claim 28  wherein components of platelet gel are injected through separate lumens of the treatment device so that said components of platelet gel become combined to form platelet gel immediately before or after entering the myocardium.